FDA — authorised 6 April 2000
- Application: NDA021086
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: ZYPREXA ZYDIS
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA authorised Zydis on 6 April 2000
Yes. FDA authorised it on 6 April 2000; FDA has authorised it.
CHEPLAPHARM holds the US marketing authorisation.